Category Archives: Glucose Monitoring

Vertex Q4 ’22 Earnings; Dario Partners with Dexcom

Two cardiometabolic-related news items have been observed: Vertex hosted its Q4 ‘22 earnings call and provided brief updates to its ongoing T1DM cell-therapy programs (press release; slides); and Dario announced an agreement with Dexcom to integrate Dexcom CGMs into Dario’s multi-chronic condition platform (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Dexcom G7 Super Bowl DTC; Medtronic Initiates 780G+DS5 GCM Trial; Forxiga Receives EU Approval for Chronic HF; Merck Initiates Vericiguat Pediatric HF Trial

Four cardiometabolic-related news items have been observed: Dexcom announced plans for a second Super Bowl DTC for the G7 CGM US launch (view press release; commercial); Medtronic initiated a trial evaluating the MiniMed 780G insulin pump used in combination with the DS5 CGM (Simplera) as well as the Medtronic extended infusion set and reservoir (view CT.gov record); Forxiga (dapagliflozin) has received EU approval to expand its HF indication regardless of LVEF (view Forxiga EPAR); and Merck initiated a Ph2/3 trial evaluating the vericiguat in pediatric patients aged 28 days to 18 years (VALOR; view CT.gov record). Below, FENIX provides highlights and insights from the respective news items including commentary on how the Medtronic study could suggest the company may not believe it can achieve iCGM designation.

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Lilly, Merck, and Roche Q4 ’22 Earnings Updates

Three cardiometabolic-related news items have been observed: Lilly (press release; slides), Merck (press release; slides), and Roche (press release; slides) hosted their respective Q4 ’22 earnings calls. Below, FENIX provides highlights and insights from the earnings calls. 

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Pfizer Q4 ’22 Earnings; Lilly Initiates Open-Label SURPASS-SWITCH-2 Study; Fractyl Health Announces Positive Week 24 REVITA-T2Di Data; Sciwind Initiates Dosing for Ph3 Ecnoglutide Trials in China; Lifescan Announces Publication of Connected BGM RWE

A series of cardiometabolic-related news items have been observed from Pfizer, Lilly, Fractyl Health, Sciwind, and Lifescan. Below, FENIX provides highlights and insights into the respective news items including thoughts on Pfizer’s oral GLP-1RA selection and and Lilly’s strategy for conducting SURPASS-SWITCH-2.

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Viatris’s Generic Dapagliflozin and Lilly’s Trulicity Pediatric Extension Receive Positive CHMP opinions; Medtronic’s Wearable Partner Files for Bankruptcy; Nemaura Looks to Raise Additional Capital

Four cardiometablic-related news items have been observed: Viatris’s generic dapagliflozin received a positive CHMP opinion for the treatment of T2DM, HF, and CKD (view opinion); Lilly’s Trulicity received a positive CHMP opinion for a label extension to include patients ages 10 years and older (view opinion); Medtronic’s wearable partner, Rockley Photonics Holdings Limited, has filed for bankruptcy (view Form 8-K); Nemaura announced it has entered into a definitive agreement of ~$8.4M registered direct offering and concurrent private placement with two healthcare-focused US institutional investors (view press release). Below, FENIX provides highlights and insights including thoughts on an acquisition opportunity for Medtronic.

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Diabetes Research Institute Appoints Matthias von Herrath as Scientific Director; Nemaura Receives First proBEAT Purchase Order from HealthFleet

Two cardiometablic-related news items have been observed: The Diabetes Research Institute announced the appointment of its new scientific director, Matthias von Herrath (view press release; LinkedIn); and Nemaura Medical announced it has received an initial purchase order for 5,000 proBEAT subscriptions from HealthFleet Inc. (view press release). Below, FENIX provides highlights and insights including commentary on Matthias von Herrath’s potential impact on the DRI’s T1DM mission in the context of his current role as VP and Senior Medical Officer for Novo Nordisk.

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Abbott Q4 ’22 Earnings; Tidepool Loop Receives FDA Clearance; Lilly to Expand Incretin Manufacturing Capacity; Novo Receives Marketing Practices Complaint; AGC Biologics to Manufacture Tzield; Nemaura Reports Positive Miboko Data; J&J Q4 ’22 Earnings; and Embecta Opens New Headquarters

A series of cardiometabolic-related news items were observed from Tidepool, Lilly, Novo, Embecta, AGC Biologics, and Nemaura. Additionally, Abbott and J&J hosted Q4 ’22 earnings calls. Below, FENIX provides highlights and insights into the respective news items including commentary on why the claims against Novo’s marketing practices seem unfounded.

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Rybelsus Approved as First-Line Therapy for T2DM; Biocon Receives Another CRL; Tandem Initiates Control-IQ 2.0 Feasibility Study in T1DM

Three cardiometabolic-related news items have been observed: Novo Nordisk announced FDA approved an updated label for Rybelsus, allowing for first-line use (view press release); Biocon received a CRL from FDA for its biosimilar Insulin-R (view announcement); and Tandem initiated a T1DM feasibility study using an updated Control-IQ 2.0 algorithm (view CT.gov record). Below, FENIX provides highlights and insights for the respective news items, including thoughts on the impact of the updated Rybelsus label.

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JPM 2023 Day 2: LLY, ABT, PODD, SNY, AZN, MRK, and GSK; Sernova Advances T1DM Cell Pouch Technology; Pfizer Initiates New Ph1 Oral GLP-1RA Trial

On the second day of JPM 2023, FENIX has provided coverage of presentations by major CVRM companies including Lilly, Abbott, Insulet, AZ, and Merck. GSK and Sanofi also presented at JPM 2023, but neither had any meaningful discussion relating to their respective CVRM portfolios. Separately, two CVRM-related news items have been observed: Sernova announced it has made progress toward a first in-human study for its cell pouch system (view press release); and Pfizer initiated a new Ph1 trial (view CT.gov record) for one of its oral GLP-1RA assets (PF-07081532).

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